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 Neygeront ® Ampoules - Manufacturer's Insert

NEYGERONT ® AMPOULES

NeyGeront ® "N" for injection (Revitorgan ® - dilutions no.64 "N")
NeyGeront ® - Sol
(Soluble)
NeyGeront ® for injection
(Revitorgan ® dilutions no.64)
NeyGeront ® - Drops
(Revitorgan ®-lingual no.64)
NeyGeront ® - vital capsules
Composition:

The active ingredients in NeyGeront ® are a blend of biomolecular organic lysates of animal origin (bovine origin) (molecular weight <106, n.d. standardized protein content): NeyGeront ® "N", NeyGeront ® drops and NeyGeront ® vital capsules also contain drug additives.

 1 ampoule (2 ml) NeyGeront ® for inj. contains depending on strength1 ampoule (2 ml) NeyGeront ® "N" for inj. contains depending on strength    
 St. I (D 12)St. II (D9)St. III (D 6)St. I (D12)St. II (D9)St. III (D6) (only in special pack)
Embryo tot.0.60 pg0.60 ng0.60 µg0.60 pg0.60 ng0.60 µg
Placenta0.10 pg0.10 ng0.10 µg0.10 pg0.10 ng0.10 µg
Amnion0.06 pg0.06 ng0.06 µg0.06 pg0.06 ng0.06 µg
Umbilical cord0.06 pg0.06 ng0.06 µg0.06 pg0.06 ng0.06 µg
Heart0.10 pg0.10 ng0.10 µg0.10 pg0.10 ng0.10 µg
Kidney0.10 pg0.10 ng0.10 µg0.10 pg0.10 ng0.10 µg
Pancreas0.20 pg0.20 ng0.20 µg0.20 pg0.20 ng0.20 µg
Intestinal mucosa0.10 pg0.10 ng0.10 µg0.10 pg0.10 ng0.10 µg
Spleen0.06 pg0.06 ng0.06 µg0.06 pg0.06 ng0.06 µg
Thymus juv.0.10 pg0.10 ng0.10 µg0.10 µg0.10 ng0.10 µg
Suprarenal gland0.10 pg0.10 ng0.10 µg0.10 µg0.10 ng0.10 µg
Parathyroid gland0.02 pg0.02 ng0.02 µg0.02 µg0.02 ng0.02 µg
Testes juv.0.06 pg0.06 ng0.06 µg0.06 µg0.06 ng0.06 µg
Pituitary body0.04 pg0.04 ng0.04 µg0.04 µg0.04 ng0.04 µg
Diencephalon0.20 pg0.20 ng0.20 µg0.20 µg0.20 ng0.20 µg
Cerebral cortex0.10 pg0.10 ng0.10 µg0.10 µg0.10 ng0.10 µg
Na-dodecylsulphate10.00 µg15.00 µg20.00 µg10.00 µg15.00 µg20.00 µg
Heparin   5x10-6 I.E.5x10-3 I.E.5.00 I.E.
Vit. E acetate   40.00 pg40.00 ng40.00 µg
Cyanocobalamin (vit. B12)   40.00 pg40.00 ng40.00 µg
Pyridoxine HCl (vit. B6)   40.00 pg40.00 ng40.00 µg
Methenolone acetate   4.00 pg4.00 ng4.00 µg
Liothyronine HCl   0.004 pg0.004 ng0.004 µg
Procaine HCl   8.00 pg8.00 ng8.00 µg

One phial (15 mg) NeyGeront ® sol contains:
4.5 mg embryo tot., 0.75 mg placenta, 0.45 mg amnion, 0.45 mg umbilical cord, 0.75 mg heart, 0.75 mg kidney, 1.5 mg pancreas, 0.75 mg intestinal mucosa, 0.45 mg spleen, 0.75 mg thymus juv., 0.75 mg suprarenal gland, 0.15 mg parathyroid gland, 0.45 mg testes juv., 0.3 mg pituitary body, 1.5 mg diencephalon, 0.75 cerebral cortex.
One dropper bottle (15 ml) of NeyGeront ® drops contains:
4.5 ng embryo tot., 0.75 ng placenta, 0.45 ng amnion, 0.45 ng umbilical cord, 0.75 ng heart, 0.75 ng kidney, 1.5 ng pancreas, 0.75 ng intestinal mucosa, 0.45 ng spleen, 0.75 ng thymus juv., 0.75 ng suprarenal gland, 0.15 ng parathyroid gland, 0.45 ng testes juv., 0.3 ng pituitary body, 1.5 ng diencephalon, 0.75 ng cerebral cortex, 37.5 x 10-3 i.u. heparin, 300.00 ng vit. E acetate, 300.00 ng cyanocobalamin (vit. B12), 300.00 ng pyridoxine HCl (vit. B6), 30.00 ng methenolone acetate, 60.00 ng procaine HCl, 0.03 ng liothyronine HCl, 150.00 (g Na-dodecyl sulphate, 0.99 ml glycerin, 45.0 mg of a mixture of methyl-, ethyl-, propyl-4-hydroxybenzoates (parabens) as preservatives, for 15 ml physiol. NaCl solution.
1 NeyGeront ® vital capsule contains:
0.37 ng embryo tot., 0.1 ng placenta, 60 pg amnion, 60 pg umbilical cord, 0.2 ng heart, 0.1 ng pancreas, 0.1 ng intestinal mucosa, 60 pg spleen, 0.2 ng thymus juv., 0.1 ng suprarenal gland, 20 pg parathyroid gland, 0.1 ng testes juv., 60 pg ovary, 40 pg pituitary body, 30 pg diencephalon, 0.2 ng cerebral cortex, 0.2 ng hepar, 5 x 10-3 i.u. heparin, 10 (g L-glutaminic acid, 4 ng methenolone acetate, 4 pg liothyronine HCl, 40 ng vit. E acetate, 40 ng cyanocobalamin (vit. B12), 40 ng pyridoxine HCl (vit. B6), 8 ng procaine HCl, 10 mg biolecithin, 1.5 ng trace elements (Fe, Co, Cu, Mg, Zn, Ca), 15 (g Na-dodecyl sulphate, 410 mg medium-chain triglycerides.
Properties:
The active ingredients in NeyGeront ® affect the biosynthesis of proteins and the associated metabolic efficiency of various cell systems. In this way, metabolism and function of the large organs are activated in a sustained manner. Mitosis at distributed exhausted cells is induced, amongst other things, and repair mechanisms at mutated DNA segments are set in motion by activation of semi-conservative DNA synthesis via endonucleases, which highlights the radio-protective effect of the factors in vivo. This explains the impressive therapeutic effects and the generally regenerating, vitalizing and strengthening action of NeyGeront ® in old people.
An improvement in the activity, alertness and mnesic abilities of elderly psychiatric patients has been observed.
Areas of application:
Premature ageing, impotence and diseases of old age, impaired growth and development, arteriosclerosis, tonic.
Dosage and application method:
NeyGeront ® for inj., NeyGeront ® "N" for inj., NeyGeront ® drops, NeyGeront ® sol and NeyGeront ® vital capsules form a system of therapy where the dose can be adjusted gradually.
NeyGeront ® for inj., /NeyGeront ® "N" for inj.:
Unless otherwise prescribed, NeyGeront ® for inj. and NeyGeront ® "N" for inj. are administered i.c., s.c., i.m., i.v. or as an additive to infusions. Immunological-tolerogenic treatment is usually given with increasing concentrations of NeyGeront ® for inj.(from strength 1 to strength III). Treatment can then be continued from strength III, strength II to strength I and again from strength I to strength III (alternating dosage). This can be followed with maintenance therapy using only strength III.
Unless otherwise prescribed, NeyGeront ® "N" for inj. is injected 3 times in the first week (Mon, Wed, Fri), twice in the second week (Mon, Thurs) at increasing concentrations (3 x strength I, 2 x strength II). In the case of allergic illnesses, injections can also be given on the first three consecutive days, then every other day up to the third week, then every third day. The course of injections can be repeated in subsequent treatments at intervals of 3-5 days. At the end of the course of injections, the i.m. or i.v. injection of NeyGeront ® sol is recommended as long as tolerance has previously been produced with NeyGeront ® for inj. at all three strengths (strength I, strength II, strength III).
NeyGeront ® sol:
NeyGeront ® sol. is administered i.m. or i.v. after tolerance has been produced with increasing concentrations of NeyGeront ® for inj. or NeyGeront ® "N" for inj. Solvent I is drawn up into a disposable syringe from the ampoule supplied, under sterile conditions, and after the septum stopper has been punctured, transferred to the phial with 15 mg NeyGeront ® sol.
The ready-to-use solution of NeyGeront ® sol should be used as soon as the solution is made.

The chosen method of application must be retained throughout treatment. Example of doses:

Mon. - 1st day3 amp.NeyGeront ® for inj.St. Is.c. or i.m.or i.v.
Tues. - 2nd day3 amp.NeyGeront ® for inj.St. Is.c. or i.m.or i.v.
Wed. - 3rd day3 amp.NeyGeront ® for inj.St. IIs.c. or i.m.or i.v.
Thurs. - 4th day3 amp.NeyGeront ® for inj.St. IIs.c. or i.m.or i.v.
Fri - 5th day3 amp.NeyGeront ® for inj.St. IIIs.c. or i.m.or i.v.
Sat - 6th day     
Sun - 7th day     
Mon - 8th day1 phialNeyGeront ® sol i.m.or i.v.
Tues - 9th day     
Wed. - 10th day     
Thurs - 11th day1 phialNeyGeront ® sol i.m.or i.v.

Rp: 3 OP NeyGeront ® for inj.
2 OP NeyGeront ® sol.
In order to ensure that the acquired tolerance is maintained, the injection-free interval should be no more than 2-3 days. If the interval is longer, treatment is repeated or the method of application is changed, another immunological-tolerogenic pre-treatment phase with NeyGeront ® for inj., strength I to strength III, is necessary.
NeyGeront ® vital capsules:
Unless the doctor prescribes otherwise, one capsule should be swallowed whole with plenty of fluid 1-2 times a day half an hour before mealtimes, every morning and evening.
NeyGeront ® drops:
NeyGeront ® drops can be taken on the tongue, sniffed up the nose, inhaled as an aerosol or rubbed into the skin or mucosa.
Unless otherwise prescribed, usually 10-20 drops 3 times a day. Nothing should be eaten or drunk 10-15 minutes before and after taking the drops. NeyGeront ® drops should not come into contact with metal. It is advisable therefore to place the drops directly in the mouth or to place them on the tongue using a plastic spoon or from the back or palm of the hand, to drop them into the nose or snort them from the back of the hand so that the liquid gets into the cavity of the pharynx. This method of application is particularly effective. NeyGeront ® drops are particularly suitable for maintenance therapy or for treatment between courses of injections. For serious illnesses, the use of NeyGeront ® for inj., NeyGeront ® "N" for inj. and NeyGeront ® sol are also recommended.
Duration of treatment:
Unless otherwise prescribed, a course of treatment consists of 15 ampoules (3 OP) NeyGeront ® for inj. and 2 phials (2 OP) NeyGeront ® sol. This treatment cycle, alternating dosages or maintenance therapy with strength III can be repeated at intervals of 1-6 months. 1 phial of NeyGeront ® sol or 1 ampoule NeyGeront ® for inj., strength III (see special pack), can be used twice a week as maintenance therapy.
Side effects:
If the dosage guidelines are followed, there should be no side effects. In exceptional cases, patients who are disposed to allergies or pre-sensitized patients may experience nausea, accelerated pulse, sensation of constriction, exanthem or local irritation at the recommended dose. In the case of NeyGeront ® sol, patients should go back to NeyGeront ® for inj., strength III, for subsequent treatment. If this is tolerated without difficulty, treatment can be continued with NeyGeront ® sol. If the mentioned symptoms occur with NeyGeront ® for inj., the dose should be reduced by one concentration stage and increased again once the symptoms have receded. Due to the content of alkyl-4-hydroxybenzoates (parabens) in NeyGeront ® drops, patients who are disposed can sometimes experience allergic reactions.
Contraindications:
None known so far.
Allergic reactions to alkyl-4-hydroxybenzoates (parabens) may occur with NeyGeront ® drops.
Interactions with other drugs:
None known so far.
Special instructions:
i.m. injection/ i.v. injection: Symptoms such as congestion in the head, fever, tiredness, depression, itching and exanthem which may occur in pre-sensitized patients can be controlled by antihistamines. Glucocorticoids are indicated if the symptoms do not recede. Anti-inflammatory topical preparations should be used to treat local irritation. As a preventative measure in cases of existing sensitization, anti-allergic agents (antihistamines) can be taken as a prophylactic 15 minutes before administration - if sensitization is severe, glucocorticoids can also be administered. After i.v. injection the patient should stay under medical observation for 30 minutes. The solution of NeyGeront ® sol must be at room temperature for the injection and should be injected slowly.
Storage instructions:
The drug should be stored at room temperature and kept dry.
Stability:
NeyGeront ® for inj., NeyGeront ® "N" for inj., NeyGeront ® sol., NeyGeront ® vital capsules and NeyGeront ® drops should not be used after the expiry date shown on the pack. The ready-to-use solution of NeyGeront ® sol should not be kept for more than 15 minutes. An opened bottle of NeyGeront ® drops should be used up within 6 weeks.
Presentation and pack sizes:

NeyGeront ® for inj.:Original pack:2ml ampoules in original packs of 1 x 5 (2 x strength I, 2 x strength II, 1 x strength III)
 Special pack:2ml ampoules in special packs of 1 x 5 (5 x strength I or 5 x strength II or 5 x strength III)
 50-pack:2ml ampoules in packs of 1 x 50 (20 x strength I, 20 x strength II, 10 x strength III) or 1 x 50 (50 x strength 1 or 50 x strength II or 50 x strength III)
NeyGeront ® "N" for inj.Original pack:2ml ampoules in original packs of 1 x 5 (3 x strength I, 2 x strength II)
 Special pack:2ml ampoules in special packs of 1 x 5 (5 x strength I or 5 x strength II or 5 x strength III)
 50-pack:2ml ampoules in packs of 1 x 50 (30 x strength I, 20 x strength II) or 1 x 50 (50 x strength 1 or 50 x strength II or 50 x strength III)
NeyGeront ® sol.:Original pack:1 phial with 15 mg NeyGeront ® sol and 1 ampoule with 2 ml solvent I (physiol. NaCl solution)
 50-pack:50 phials each with 15 mg NeyGeront ® sol and 50 ampoules each with 2 ml solvent I (physiol. NaCl solution)
NeyGeront ® vital capsulesOriginal pack:42 enteric-coated capsules of 0.5 ml
 Treatment pack:126 enteric-coated capsules of 0.5 ml
NeyGeront ® drops:Original pack:Dropper bottle containing 15 ml
 50-pack:50 dropper bottles containing 15 ml

NeyGeront ® sol. has been freeze-dried without using any chemicals. Consequently, there may be optical differences from batch to batch but they have no effect on the drug's content or effectiveness.

Store drugs carefully! Keep out of the reach of children!

Ethical drug NeyGeront ® for inj.: Reg. no: 1742
Edition: 3/97 NeyGeront ® "N" for inj.: Reg. no: N 365-2-4
NeyGeront ® sol: Reg. no: 1742
NeyGeront ® vital capsules: Reg. no.: 11649
NeyGeront ® drops: Reg. no.: N 591-2
® = Registered trademark

The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.
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